Korea to expand requirements, monitoring of clinical trials

Broadening its oversight of clinical trials for which it has become a regional hub over the past decade, South Korea this August announced a five-year plan to broaden testing opportunities for new drugs while better protecting the rights of patients participating in trials.

In unveiling the plan, officials at South Korea’s Ministry of Food and Drug Safety said they aim to better manage the safety of clinical trials, make the trials more internationally competitive and have better communications with patients.

The Ministry plans to step up inspections of clinical trial sites and to require regular reporting by pharmaceutical companies of the safety of all drugs under investigation, not just those to which patients have had adverse reactions.

Under the plan, a government review committee will be established over the next two years to assess clinical trials, and a help center will be established to offer information, counseling and education for clinical trial participants.

Offsetting the more stringent requirements for drug makers is a plan to speed the approval of certain drugs already tested in multinational Phase 3 trials in certain other countries, the U.S. among them. The new approval system is designed to recognize the readiness for market of drugs that have already undergone significant monitoring and fact-finding studies.